Mild Hypothermia During Intracranial Aneurysm Clipping

NCT02544256 | Withdrawn

• 1 other identifier: 201507-S16P
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Microcirculation; Mild Hypothermia, Induced; Subarachnoid Hemorrhage, Aneurysmal; Aneurysmal Clipping; Vasospasms

Outcome Measures

Primary Outcomes (1)

• Changes in Sidestream Dark Field (SDF) imaging variables

  brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe

  1 and 2 hours after skin incision

Secondary Outcomes (2)

• Changes in diameter of small brain arteries at operating site

  1 and 2 hours after skin incision

• Occurrence of vasospasms

  within the first 14 days after surgery

Other Outcomes (2)

• Days of hospital stay

  participants will be followed for the duration of hospital stay, an expected average of 3 weeks

• Glasgow outcome score (GOS) on discharge

  2 weeks after operation

Study Arms (2)

Mild hypothermia

EXPERIMENTAL

After induction to general anaesthesia the patients will be cooled to 33° C. Targeted body temperature 33,8° C - 34,8° will be maintained up to the end of microcirculation measurement after aneurysm clipping.

Procedure: Mild hypothermia

Normothermia

NO INTERVENTION

The body temperature will be maintained in the range 35,8° C - 36,8° C.

Interventions

Mild hypothermia PROCEDURE

Mild hypothermia during surgical clipping of brain aneurysm will be reached by cooling to body temperature 33,8° C - 34,8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping.

Mild hypothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute subarachnoidal hemorrhage based on ruptured aneurysm
• Hunt and Hess scale 1-4
• Clipping up to 72 hours after the rupture

You may not qualify if:

• Known cryoglobulinemia

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Vlasta Dostalova, MD, PhD

  University Hospital Hradec Kralove

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dostalova Vlasta, MD, PhD

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 9, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

CZ (1)